1. Field of the Invention
The present invention relates generally to a modular packaging system for packaging and organizing surgical items which must be contained under sterile conditions, and is particularly directed to such a packaging system for securely packaging surgical items which are sterilized by diverse means.
2. Description of the Prior Art
Modern surgical procedures require the use of a large variety of diverse items, all of which must be sterile. Common sterilization techniques include GAMMA irradiation, E Beam, ETO and steam, each of which has attendant advantages and disadvantages. For example, GAMMA irradiation is often preferred as a means of sterilization, since it is economical, absolute, and since products sterilized in such manner do not require sterility testing or post sterilization quarantine. The GAMMA irradiation technique does have certain disadvantages, however, including the tendency to discolor certain plastics and to physically degrade certain materials. Products which cannot be sterilized by GAMMA irradiation are typically sterilized either with ethylene oxide (ETO) or with steam.
The packaging of sterile surgical articles used in specific surgical procedures allows such articles to be maintained under aseptic conditions within the package during storage and organizes the commonly needed items specific to the surgical procedure at hand. For instance, most hospitals and outpatient surgery centers order the majority of their disposable products used in one surgical procedure in one package, sometimes referred to as a "procedure pack." The prior art packaging systems and methods have generally been designed to contain articles which may be sterilized by the same means within the same container. When it is desired to provide, in a single unit, diverse sterile articles which would require different methods of sterilization, the common practice is to package the diverse article separately.
In the area of ophthalmic surgical procedures, the present industry custom is to place a number of components, including products such as surgical drapes, surgical instruments and various adjunct pharmaceutical products in plastic bags. All of these products must be sterilized and maintained in a sterile condition prior to opening the package in which they are contained in the operating room. Since different types of sterilization are required in conjunction with different types of products, a large plastic bag containing surgical drapes and other products may need to be sterilized by means different from that utilized to sterilize an adjunct pharmaceutical product, such as a bottle of irrigating fluid. The present industry practice is to attach the adjunct pharmaceutical product or products in a separate bag which is taped or otherwise attached to the plastic bag containing the surgical drapes and associated products. This practice is referred to as "piggybacking."
There are a number of drawbacks to the present industry practice as previously described. Plastic bags containing surgical products are relatively cumbersome, and therefore difficult for operating room personnel to open and disassemble. Additionally, the present method of packaging does not allow for convenient storage, since large plastic bags containing products cannot be easily stored by means of stacking. Finally, plastic bags offer little, if any, protection for the contents of the bag from physical damage due to impact during shipping or other handling.
A need thus exists for a modular surgical packaging system for packaging various products utilized during surgical procedures which is an improvement upon the use of flexible plastic bags.
A need also exists for such a modular packaging system which provides a convenient method for packaging surgical products which are sterilizable by diverse means.
A need also exists for such a packaging system which more effectively organizes the components being packaged including surgical drapes, surgical instruments and various adjunct pharmaceutical products.
A need also exists for such a packaging system which can be stacked efficiently for convenient storage and which effectively protects the contents of the packaging system from physical damage during normal use and handling.
A need also exists for such a packaging system which is simple in design and economical to manufacture.